Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:

To establish the maximum tolerated dose (MTD) of radiation that can be delivered to the prostate gland and immediate surrounding tissues in patients with carcinoma of the prostate using three dimensional conformal radiation therapy (3D-CRT). [ Time Frame: From registration to approximately 18 months from the start of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To quantify the normal tissue toxicity rate (normal tissue complication probability (NTCP)) for rectum and bladder using 3D-CRT [ Time Frame: From registration to approximately 18 months from the start of treatment ] [ Designated as safety issue: No ]

To evaluate local control by clinical, pathologic, and PSA (stable in normal range) determinations [ Time Frame: From registration to the date of progression or last follow-up. Analysis will occur after the primary endpoint analysis. ] [ Designated as safety issue: No ]

Distant metastasis and survival [ Time Frame: From registration to the date of death or last follow-up. Analysis will occur after the primary endpoint analysis. ] [ Designated as safety issue: No ]

OBJECTIVES: I. Determine the maximum tolerated dose of 3-dimensional conformal radiotherapy to the prostate gland and immediately surrounding tissues in patients with stage II or III adenocarcinoma of the prostate. II. Determine the normal tissue toxicity rate of this regimen in the rectums and bladders of these patients. III. Determine local control by clinical and pathologic examination and by PSA determinations in patients treated with this regimen. IV. Determine the distant failure and overall survival of patients treated with this regimen.

OUTLINE: This is a dose escalation study. Patients are stratified according to 1 of the following 3 prognostic groups: Group 1: T1b-c or T2a-b with combined PSA/Gleason (CPG) score 15 and under Group 2: T1b-c or T2a-b with CPG score more than 15, or any T2c with PSA less than 70 ng/mL Group 3: T3 with prostate specific antigen (PSA) less than 70 ng/mL Patients receive 3-dimensional (3-D) conformal radiotherapy 5 days a week for 7.6, 8.2, or 8.8 weeks. Cohorts of 120-270 patients receive escalating doses of 3-D conformal radiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 20% of patients experience dose-limiting toxicity. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 549-801 patients (120-204 patients for the first dose level, 237-321 patients for the second dose level, and 192-276 patients for the third dose level) will be accrued for this study within 4.75 to 5.25 years.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Male

Accepts Healthy Volunteers:

No

Criteria

DISEASE CHARACTERISTICS: Previously untreated adenocarcinoma of the prostate T1b-c or T2a-b with a Gleason score more than 5 and PSA greater than 4 ng/mL OR Any T3 PSA under 70 ng/mL within 3 weeks prior to entry and at least 10 days after prostate biopsy No biopsy proven regional nodal involvement No distant metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80-100% Hematopoietic: White blood cell (WBC) count of at least 4,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 11 g/dL Hepatic: Not specified Renal: Not specified Other: No major medical or psychiatric illness that would preclude study No other malignancy within the past 5 years

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00002602